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Comparative Study of the Non-dependent Continuous Positive Airway Pressure and High-frequency Positive-pressure Ventilation on Fluid Responsiveness During One-lung Ventilation for Thoracoscopic Surgery
Sponsor study identifier
interventional
62
1 country
1
Study Start
January 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The stroke volume variation (SVV), measured using the Vigileo-FloTrac system (Edwards Lifescience, Irvine, CA), has been shown to able to predict fluid responsiveness during one-lung ventilation (OLV) in patients undergoing pulmonary lobectomy (sensitivity: 82.4%, specificity: 92.3%).1 Many parameters such as tidal volume (TV),1-2 positive end-expiratory pressure (PEEP),3 respiratory rate (RR), 4 chest and lung compliance,5 heart rate and rhythm, and ventricular function and afterload,6-7 all have been documented to have effects on the SVV. SVV is calculated as the variation of beat-to-beat SV from the mean value during the most recent 20 seconds of data: SVV = (SVmax - SVmin)/SVmean, where SVmax, SVmin, and SVmean are, respectively, the maximum, minimum, and mean SV determined by the system. SVV may not be sufficiently sensitive to predict fluid responsiveness in patients with right ventricular (RV) dysfunction due to concomitant increases in RV afterload, that lead to a decrease in preload variation and subsequent inaccuracy in SVV measurements.8 OLV may increase airway pressure, resulting in increases in the RV afterload, end-diastolic volume, and stroke work index, thus impeding RV function.9-11The increases in the right ventricular afterload may exaggerate the cyclic variation in stroke volume.12 In the authors' previous study,9 they found that the high-frequency positive-pressure ventilation (HFPPV) was superior to continuous positive-airway pressure (CPAP) for OLV, resulting in significantly higher RV ejection fraction, lower RV afterload and higher arterial oxygenation, whereas the former limiting the adequate operative field visualization during video-assisted thoracoscopic surgery (VATS).13 The effects of the nondependent lung ventilation with HFPPV and CPAP on the SVV and fluid responsiveness during OLV has not yet been studied.
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June 2020
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 12, 2014
Actual (reported)July 16, 2014
Actual (reported)January 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2020
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June 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Fluid responsiveness
To explore the ability of SVV to predict fluid responsiveness with ROC plots
5 min after volume loading
Heart rate
5 min before volume loading, 5 min after volume loading
Stroke volume variation
5 min before volume loading, 5 min after volume loading
Mean blood pressure
5 min before volume loading, 5 min after volume loading
Cardiac index
5 min before volume loading, 5 min after volume loading
Stroke Volume Index
5 min before volume loading, 5 min after volume loading
TV 2 mL kg-1 PBW, I:E ratio \> 0.3, RR 60 breaths min-1 and a FGF of \< 2 L min-1, using a second identical ventilator with low compliant internal circuit
CPAP of 2 cm H2O
King Fahd Hospital of the University
Khobar, Eastern Province, 31952, Saudi Arabia
Abdulmohsen A Al Ghamdi, MD
Chairman of Anesthesiology Dept
Mohamed R El Tahan, MD
Imam Abdulrahman Bin Faisal University
First Submitted
July 12, 2014
First Posted
July 16, 2014
Study Start
January 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 2020
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 24, 2018
Record last verified: 2018-05
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Source: ClinicalTrials.gov.
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